UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of January 2026
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Issued: 7th January
2026, London UK
GSK's Shingrix (Recombinant Zoster Vaccine) prefilled
syringe presentation approved by the European
Commission
●
Prefilled syringe
offers healthcare professionals a convenient administration
option
● New presentation will begin rolling out across EU
countries in 2026
●
Shingles affects
approximately 1.7 million people in Europe each
year,[1] with
certain chronic conditions linked to a higher risk of
shingles
[2],[3]
GSK plc (LSE/NYSE: GSK) today announced the European Commission's
(EC) approval of Shingrix (GSK's Recombinant Zoster Vaccine or RZV) in
a prefilled syringe. The current vaccine presentation comprises two
vials, one with a lyophilised powder antigen and another with a
liquid adjuvant. The lyophilised powder antigen requires
reconstitution, where the suspension in the adjuvant vial is
withdrawn and injected into the antigen vial. The new prefilled
syringe simplifies the vaccine administration process for
healthcare professionals by removing the need to undertake these
steps prior to administration.
Tony Wood, Chief Scientific Officer, GSK, said: "This
new presentation of Shingrix has
been designed to improve ease of administration, helping healthcare
professionals to provide protection against shingles. Shingles is a
painful disease that can have serious and long-lasting
complications. It affects millions of people each year in Europe,
often imposing a greater burden on people living with common
chronic diseases such as cardiovascular disease and diabetes. GSK
is proud to support the healthcare community by making
administration of its shingles vaccine easier."
This approval is based on data confirming technical comparability
between the prefilled syringe and the existing vaccine
presentation.[4] The
new presentation does not involve a change in indication or
dosing.
About shingles
Shingles is caused by the reactivation of the varicella-zoster
virus (VZV), the same virus that causes
chickenpox.2 Globally,
up to 1 in 3 adults will develop shingles in their
lifetime.2,[5],[6],[7] Over
90% of adults have the VZV dormant in their nervous system, waiting
to reactivate.2,[8],[9],[10] In
addition to advancing age, chronic conditions like cardiovascular
disease, chronic kidney disease, chronic obstructive pulmonary
disease, asthma, and diabetes are all linked to higher risk of
shingles.2,3
Shingles typically presents as a rash, with painful blisters across
the chest, abdomen or face.8 Following
the rash, up to 30% of people experience post-herpetic
neuralgia (PHN),[11] a
long-lasting nerve pain that can last weeks or months and can
occasionally persist for several years.2
About Shingrix (Recombinant Zoster Vaccine or
RZV)
Shingrix combines
an antigen, glycoprotein E, with an adjuvant system,
AS01B,
and may help overcome the natural age-related decline in responses
to immunisation that contributes to the challenge of protecting
adults aged 50 and over from shingles.[12],[13] RZV
is not indicated to prevent primary varicella infection
(chickenpox). The use of RZV should be in accordance with official
recommendations and local product label.
GSK's shingles vaccine has been approved in the European Union for
the prevention of herpes zoster (HZ) and PHN in adults aged 50
years or older since 2018; and in adults 18 years or older at
increased risk of HZ, since 2020.
Please refer to the Product Information (PI) for important dosage,
administration, and safety information in Europe available at this
link:
https://www.ema.europa.eu/en/medicines/human/EPAR/shingrix
About GSK
GSK is a global biopharma company with a purpose to unite science,
technology, and talent to get ahead of disease together. Find out
more at www.gsk.com.
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GSK enquiries
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Media:
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Tim
Foley
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(London)
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Simon
Moore
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(London)
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Kathleen
Quinn
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603 5003
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(Washington
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Lyndsay
Meyer
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302 4595
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(Washington
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Alison
Hunt
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+1 540 742 3391
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(Washington
DC)
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Investor
Relations:
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Constantin
Fest
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+44 (0)
7831 826525
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Mick
Readey
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+44 (0)
7990 339653
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(London)
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Steph
Mountifield
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+44 (0)
7796 707505
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(London)
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Sam
Piper
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+44 (0)
7824 525779
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Frannie
DeFranco
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+1 215
751 3126
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(Philadelphia)
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Cautionary statement regarding forward-looking
statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described in the "Risk
Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q3 Results for 2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
[1] Pinchinat
et al. Similar herpes zoster incidence across Europe: results from
a systematic literature review. BMC Infect Dis.
2013;13:170.
[2] Harpaz
R, et al. Advisory Committee on Immunization Practices (ACIP),
Centers for Disease Control and Prevention (CDC). Prevention of
herpes zoster: recommendations of the Advisory Committee on
Immunization Practices (ACIP). MMWR Recomm Rep.
2008;57(RR-5):1-30.
[3] Steinmann
et al. Risk factors for herpes zoster infections: a systematic
review and meta-analysis unveiling common trends and heterogeneity
patterns. Infection. 2024;52(3):1009-1026. doi:
10.1007/s15010-023-02156-y. REF-224255.
[4] GSK.
Data on file.
[5] Australian
Institute of Health and Welfare. Shingles in Australia. Available
at: https://www.aihw.gov.au/getmedia/759199ff-f5c8-421d-a572-aaa984a02b49/aihw-phe-236_shingles.pdf.aspx.
Last Accessed: November 2025.
[6] Lee
C, et al. Lifetime risk of herpes zoster in the population of
Beijing, China. Public Health Pract (Oxf).
2023;5:100356.
[7] Curran
D, et al. Meta-Regression of Herpes Zoster Incidence Worldwide.
Infect Dis Ther. 2022;11(1):389-403.
[8] Mueller,
N.H., et al. Varicella
zoster virus infection: clinical features, molecular pathogenesis
of disease, and latency. Neurologic clinics.
2008;26(3):675-97.
[9] Johnson,
R.W., et al. Herpes zoster epidemiology, management, and disease
and economic burden in Europe: a multidisciplinary
perspective. Therapeutic
advances in vaccines.
2015;3(4):109-20.
[10] Bricout,
H., et al. Herpes zoster-associated mortality in Europe: a
systematic review. BMC public health.
2015;15:466.
[11] Kawai,
K., et al. Systematic review of incidence and complications of
herpes zoster: towards a global perspective. BMJ open.
2014;4(6).
[12] Cunningham,
AL, et al. Efficacy of the Herpes Zoster Subunit Vaccine in Adults
70 Years of Age or Older. New England Journal of Medicine.
2016;375(11):1019-32.
[13] The
GSK proprietary AS01 adjuvant system contains QS-21 Stimulon®
adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of
Agenus Inc. (NASDAQ: AGEN), MPL and liposomes.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GSK plc
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(Registrant)
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Date: January
07, 2026
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By:/s/ VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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